EP0092999B1 - Wundverband - Google Patents

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Publication number
EP0092999B1
EP0092999B1 EP83302316A EP83302316A EP0092999B1 EP 0092999 B1 EP0092999 B1 EP 0092999B1 EP 83302316 A EP83302316 A EP 83302316A EP 83302316 A EP83302316 A EP 83302316A EP 0092999 B1 EP0092999 B1 EP 0092999B1
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EP
European Patent Office
Prior art keywords
weight
dressing
adhesive layer
inches
water
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Revoked
Application number
EP83302316A
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English (en)
French (fr)
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EP0092999A3 (en
EP0092999A2 (de
Inventor
John M. Pawelchak
Frank M. Freeman
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ER Squibb and Sons LLC
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ER Squibb and Sons LLC
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Application filed by ER Squibb and Sons LLC filed Critical ER Squibb and Sons LLC
Priority to AT83302316T priority Critical patent/ATE74280T1/de
Publication of EP0092999A2 publication Critical patent/EP0092999A2/de
Publication of EP0092999A3 publication Critical patent/EP0092999A3/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
    • A61F13/0209—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings comprising superabsorbent material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0213—Adhesive bandages or dressings with fluid retention members the fluid retention member being a layer of hydrocolloid, gel forming material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/022—Adhesive bandages or dressings with fluid retention members having more than one layer with different fluid retention characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/0253—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/0256—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the parametric properties of the adhesive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/225—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/58—Adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0052—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/008—Hydrogels or hydrocolloids

Definitions

  • This invention is directed to an occlusive dressing useful for treating skin lesions such as dermal ulcers and pressure sores.
  • US Patent US-A-3,972,328 describes a medical dressing or bandage which comprises (i) an adhesive layer comprising a pressure-sensitive rubbery elastomer adhesive material such as a mixture of polyisobutylenes of a molecular weight of 10,000 to 11,700 and 81,000 to 99,000 having intimately dispersed therein a water-soluble or swellable hydrocolloid or a mixture of hydrocolloids such as gelatin and sodium carboxymethylcellulose, a tackifier such as terpene resin and a plasticiser or solvent such as mineral oil, (ii) a semi-open cell polymeric foam layer and (iii) an outer polymeric film coating.
  • a pressure-sensitive rubbery elastomer adhesive material such as a mixture of polyisobutylenes of a molecular weight of 10,000 to 11,700 and 81,000 to 99,000 having intimately dispersed therein a water-soluble or swellable hydrocolloid or a mixture of hydrocolloids such as gelatin and sodium carboxymethylcellulose,
  • French Patent Application FR-A-2393566 describes a hand-mouldable composition primarily for adhering an ostomy device to the skin.
  • the composition comprises a pressure-sensitive adhesive material such as a lower molecular weight polyisobutylene, and a hydrocolloid material.
  • GB Patent Application GB-A-2000683 describes an ostomy appliance having a faceplate to which is applied a homogeneous mixture of gelatin, pectin, sodium carboxymethylcellulose and polyisobutylene as an adhesive.
  • an occlusive multi-layered dressing comprising an adhesive layer which, in use, contacts the wound and surrounding normal skin, an intermediate layer, of semi-open-cell polymeric foam, and an outer moisture impervious polymeric film coated or laminated to the upper surface of said foam layer
  • said wound and skin contacting adhesive layer consists essentially of a homogeneous blend of from about 35% to about 50% by weight of one or more low molecular weight polyisobutylenes which act as pressure sensitive adhesive materials and from about 45% to about 65% by weight of one or more water dispersable hydrocolloids selected from sodium carboxymethylcellulose, calcium carboxymethylcellulose, pectin, gelatin, guar gum, locust bean gum, collagen, and gum karaya.
  • One embodiment of the occlusive dressing 10 of this invention as shown in figs 1 and 2 comprises a first adhesive layer 14 which is formulated from materials selected to interact with fluid discharged from the wound as well as forming a fluid-tight bond with the healthy skin around the wound so as to seal the dressing to the skin.
  • the dressing of this embodiment includes a second adhesive layer 13 formulated of materials which can be cast onto foam layer 12 and will form an aggressive bond when pressed into contact with adhesive layer 14.
  • the layer 12 is a semi-open cell elastic or flexible foam.
  • the outer layer 11 can be a polymeric film or a skin formed on the top of foam layer 12 which serves to protect the exposed surface of the dressing from contamination by water or soil.
  • dressing 30 includes a layer of deodorizing material designated 31 interposed between adhesive layers 14 and 13.
  • dressing 50 omits second adhesive layer 13 and has adhesive layer 14 laminated directly to the semi-open cell elastic foam 12.
  • Adhesive layer 14 comprises a homogeneous blend of one or more pressure sensitive adhesive materials which are low molecular weight polyisobutylenes, and one or more water dispersable hydrocolloidal materials of the group defined above, in the percentages defined above.
  • Adhesive layer 13 comprises a homogeneous blend of one or more pressure sensitive adhesive materials, one or more water dispersable hydrocolloidal materials, a tackifier, and a plasticizer or solvent. Additionally, one or more thermoplastic elastomers may be included with the pressure sensitive adhesive materials in layer 13 and one or more water swellable cohesive strengthening agents and/or one or more natural or synthetic polymers capable of developing elastomeric properties when hydrated may be included with the hydrocolloidal materials in layer 13.
  • Suitable pressure sensitive adhesive materials for inclusion in layer 13 are various natural or synthetic viscous or elastomeric substances such as natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, polyisobutylene, etc.
  • Low molecular weight polyisobutylenes having a viscosity average molecular weight of from about 36,000 to about 58,000 (Florey) possessing pressure sensitive adhesive properties are preferred.
  • Such polyisobutylenes are commercially available under the trademark Vistanex from Exxon as grades LM-MS and LM-MH and may also be used for layer 14.
  • thermoplastic elastomers can be included in the pressure sensitive adhesive component of layer 13. These elastomers impart the properties of rubber-like extensibility and both rapid and complete recovery from modular strains to the pressure sensitive adhesive component.
  • Suitable thermoplastic elastomers include medium molecular weight polyisobutylenes having a viscosity average molecular weight of from about 1,150,000 to 1,600,000 (Florey), butyl rubber which is a copolymer of isobutylene with a minor amount of isoprene having a viscosity average molecular weight of from about 300,000 to about 450,000 (Florey), and styrene copolymers such as styrene-butadienestyrene (S-B-S), styrene-isoprene-styrene (S-I-S), and styrene-ethylene/butylene-styrene (S-EB-S) which are commercially available
  • thermoplastic elastomers are butyl rubber having a viscosity average molecular weight of about 425,000 (commercially available from Exxon as grade 077), polyisobutylene having a viscosity average molecular weight of about 1,200,000 (commercially available under the trademark Vistanex from Exxon as grade L-100), and styrene-isoprene-styrene (S-I-S)copolymers (commercially available from Shell as Kraton D1107).
  • the pressure sensitive adhesive component including the optional thermoplastic elastomer is present in adhesive layer 13 at from about 30% to about 70% by weight of the composition, preferably from about 35% to about 50% by weight.
  • the thermoplastic elastomer can be employed at up to three times the weight of the pressure sensitive elastomeric substances but preferably the theromoplastic elastomer if present will be at from about 20% to about 150% by weight of the pressure sensitive elastomeric substance.
  • Adhesive layer 13 includes from about 10% to about 65% by weight of one or more water dispersable hydrocolloid materials. Suitable hydrocolloid materials include sodium or calcium carboxymethylcellulose, pectin, gelatin, guar gum, locust bean gum, collagen and gum karaya. Adhesive layer 13 may also include up to about 50% by weight of one or more water swellable cohesive strengthening agents and/or one or more natural or synthetic polymers capable of developing elastomeric properties when hydrated provided that the water soluble hydrocolloid gums, water swellable cohesive strengthening agents, and hydratable polymers together are present at no more than about 70% by weight of adhesive layer 13.
  • Suitable water swellable cohesive strengthening agents include finely divided substantially water insoluble cross-linked sodium carboxymethylcellulose such as that commercially available under the trademark Aqualon or that described in U.S. Patent 3,589,364 and available commercially from the Buckeye Cellulose Corp., finely divided substantially water insoluble starch-acrylonitrile graft copolymer such as that described in U.S. Patent 3,661,815 and commercially available from the Grain Processing Corp., and finely divided substantially water insoluble cross-linked dextran such as that commercially available under the trademark Sephadex.
  • Suitably hydratable polymers are gluten and long chain polymers of methyl vinyl ether/maleic acid, preferably, the long chain polymers of methyl vinyl ether/maleic acid commercially available under the trademark Gantrez from GAF Inc.
  • the maleic acid moiety in the polymer may be intact (Gantrez S-97), may be an anhydride (Gantrez AN-169), or may be a metal salt such as the mixed sodium/calcium salts (Gantrez AT-955).
  • the water dispersable hydrocolloids, the optional water swellable cohesive strengthening agents, and the optional hydratable polymers are present at from about 45% to about 65% by weight of adhesive layer 14 and from about 30% to about 50% by weight of adhesive layer 13.
  • the water dispersable hydrocolloids provide wet tack for adhesive layers 14 and 13 while the pressure sensitive adhesive component provides dry adhesion and imparts structural integrity to layers 14 and 13.
  • Adhesive layer 13 also includes from about 5% to about 15% by weight of a plasticizer or solvent such as mineral oil or petrolatum with mineral oil being preferred and from about 15% to about 25% by weight of a tackifier such as a terpene resin.
  • a plasticizer or solvent such as mineral oil or petrolatum with mineral oil being preferred
  • a tackifier such as a terpene resin
  • Small amounts, i.e., less than 5% by weight, of other ingredients may be included within adhesive layers 14 and 13.
  • an antioxidant such as butylated hydroxyanisole or butylated hydroxytoluene
  • a deodorant such as chlorophyllins
  • a perfume agent may be included.
  • small amounts of a pharmacologically active ingredient can be included in adhesive layer 14.
  • an antibiotic or antimicrobial agent such as neomycin, an antiseptic agent such as povidone iodine, and an antiinflammatory agent such as hydrocortisone or triamcinolone acetonide.
  • the semi-open cell elastic or flexible foam layer 12 can be formed from various elastomer materials such as polyester or polyether polyurethane foams, styrene-butadiene foams, certain rubber based foam, etc.
  • the material should, of course, be non-toxic and stable.
  • the preferred material is a flexible polyurethane foam having from about 50 to about 100 cells per linear inch (2.54 cm) with about 80 cells per linear inch (2.54 cm) being most preferred.
  • semi-open it is meant that the percentage of open or ruptured cells is from about 30 to about 85%.
  • the outer layer 11 can be a polymeric elastic or flexible film coating formed from a water impermeable pliable elastomer material such as flexible polyurethane, polyacrylate, polyethylene,etc.
  • Layer 11 can be a skin of such polymeric material flame laminated to the top of foam layer 12 by means of heat and/or pressure.
  • the exposed sides of polymeric foam layer 12 can also be coated or heat and/or pressure treated to form an impermeable film or skin.
  • Polyurethane is the preferred material for film or skin 11.
  • adhesive layer 14 will vary in thickness from about 0.02 inches (0.5 mm) to about 0.1 inches (2.54 mm), preferably about 0.05 inches (1.27 mm), adhesive layer 13 will vary in thickness from about 0.005 inches (0.127 mm) to about 0.02 inches (0.5 mm), preferably about 0.015 inches (0.38 mm), foam layer 12 will vary in thickness from about 0.03 inches (0.76 mm) to about 0.1 inches (2.54 mm), preferably about 0.065 inches (1.65 mm) and outer layer or skin 11 will vary in thickness from about 0.001 inches (0.0254 mm) to about 0.003 inches (0.076 mm), preferably about 0.002 inches (0.05 mm).
  • a layer of deodorizing material can be included between the two adhesive layers.
  • Suitable deodorizing materials include a sheet of foamed polymeric material such as polyurethane having a large number of activated carbon particles bound to the matrix of the foam. Such a material is commercially available under the tradename Bondina.
  • Another type of deodorizing material is a paper or felt like substance containing activated carbon such as that commercially available under the tradename K-felt (Toyobo) or Getter paper (Mead).
  • the layer of deodorizing material will vary from about .010 to 0.100 inches (0.254 to 2.54 mm).
  • the dressing 10 is prepared as follows. First, adhesive layer 14 is prepared by forming a homogeneous dispersion of the pressure sensitive adhesive material with a heavy duty mixer, e.g., a kneader mixer or sigma blade mixer. The hydrocolloid gums, water swellable cohesive strengthening agents, hydratable polymers, and any other optional ingredients are added and mixing is continued until a homogeneous dough is formed. This dough is then extruded into a thick slab which is thinned down by pressure rollers to the desired thickness.
  • a heavy duty mixer e.g., a kneader mixer or sigma blade mixer.
  • the hydrocolloid gums, water swellable cohesive strengthening agents, hydratable polymers, and any other optional ingredients are added and mixing is continued until a homogeneous dough is formed. This dough is then extruded into a thick slab which is thinned down by pressure rollers to the desired thickness.
  • adhesive layer 13 is prepared by forming a mixture of the hydrocolloid gums, pressure sensitive adhesive materials, tackifier and plasticizer, as well as other optional ingredients such as thermoplastic elastomers, water swellable cohesive strengthening agents, hydratable polymers, antioxidants, etc., in an organic solvent such as heptane or hexane.
  • the resulting adhesive slurry is then applied to a web of silicone coated release paper and the solvent is evaporated. Upon drying the hydrocolloids are dispersed throughout the adhesive layer.
  • This adhesive material is then compressed with a laminate of semi-open cell flexible polymeric foam having a water impermeable polymeric coating or skin on one side.
  • silicone coated release paper is stripped away from adhesive layer 13 and adhesive layers 13 and 14 are pressed together with heat to form the dressing. Silicone coated release paper can then be applied to the exposed surface of adhesive layer 14 and the dressing can be cut to the desired shape and packaged. After packaging, the dressing can be sterilized by gamma irradiation.
  • Dressing 30 is prepared in a similar manner except that a layer of deodorizing material is laminated between adhesive layers 14 and 13.
  • dressing 30 can be prepared by first laminating adhesive layer 13 directly to the layer of deodorizing material 31 and then attaching this adhesive coated material to foam layer 12.
  • adhesive layer 14 is prepared as described above and is then laminated while warm directly to foam layer 12 by means of pressure.
  • a dressing was prepared having the following composition
  • Adhesive layer 14 was prepared as follows. A premix was prepared by blending 1.4 kg. of gelatin, 1.4 kg. of pectin, and 1.4 kg. of sodium carboxymethylcellulose. The blended premix was added to a heavy duty sigma blade-type mixer followed by the addition of 1.4 kg. of polyisobutylene. After mixing for 10 minutes, an additional 1.4 kg. of polyisobutylene was added and mixing continued until a homogeneous dough was formed (about 10 to 20 minutes). This dough mass while hot and soft was extruded and thinned down by pressure rollers to a thickness of about 0.05 inches (1.27 mm).
  • a laminate of adhesive layer 13 to semi-open cell polymeric foam (layers 12 and 11) was prepared as follows.
  • This adhesive layer was laminated to a semi-open cell polyurethane foam of 0.065 inches (1.65 mm) thickness having a polyurethane skin of about 0.002 inches (0.05 mm) thickness on one surface by gently compressing the adhesive layer to the foam by passing through pressure rollers.
  • the silicone coated release paper was then stripped from adhesive layer 13 and adhesive layer 13 and adhesive layer 14 were compressed together by passing through pressure rollers. Silicone coated release paper was then pressed onto the exposed surface of adhesive layer 14. The resulting dressing was cut into the desired shape and packaged.
  • the wound packing material is a granular product of from about 10 to about 40 mesh particle size and comprises a water dispersable hydrocolloidal material or a mixture of such materials.
  • the granular product can also optionally include up to about 50% by weight of one or more water swellable cohesive strengthening agents and/or one or more hydratable polymers.
  • Suitable water dispersable hydrocolloidal materials include sodium and calcium carboxymethylcellulose, pectin, gelatin, guar gum, locust bean gum, collagen, and gum karaya.
  • Suitable water swellable cohesive strengthening agents include finely divided substantially water insoluble cross-linked sodium carboxymethylcellulose such as that commercially available under the trademark Aqualon or that described in U.S.
  • Patent 3,589,364 and available commercially from the Buckeye Cellulose Corp., finely divided substantially water insoluble starch-acylonitrile graft copolymer such as that described in U.S. Patent 3,661,815 and commercially available from the Grain Processing Corp., and finely divided substantially water insoluble cross-linked dextran such as that commercially available under the trademark Sephadex.
  • Suitably hydratable polymers are gluten and long chain polymers of methyl vinyl ether/maleic acid, preferably, the long chain polymers of methyl vinyl ether/maleic acid commercially available under the trademark Gantrez from GAF Inc.
  • the maleic acid moiety in the polymer may be intact (Gantrez S-97), may be an anhydride (Gantrez AM-169), or may be a metal salt such as the mixed sodium/calcium salts (Gantrez AT-955).
  • Small amounts, i.e., less than 5% by weight, of other ingredients may be included within or sprayed onto the granules.
  • an antioxidant such as butylated hydroxyanisole or butylated hydroxytoluene
  • a deodorant such as chlorophyllins
  • a perfume agent may be included.
  • small amounts of a pharmacologically active ingredient can be included within or sprayed onto the granules.
  • an antibiotic or antimicrobial agent such as neomycin
  • an antiseptic agent such as povidone iodine
  • an antiinflammatory agent such as hydrocortisone or triamcinolone acetonide.
  • the granules preferably contain at least 70% by weight of one or more water dispersable hydrocolloids selected from pectin, gelatin, sodium carboxymethylcellulose, and collagen with a granular product consisting of an equal weight percent mixture of pectin, gelatin, and sodium carboxymethylcellulose being most preferred.
  • the granular material can be prepared from the powder ingredients by dry compaction, wet granulation, or fluidized bed granulation techniques.
  • the dry compaction method involves blending the component powders, compacting into a slab, and milling the slab to the desired particle size. The milled material is sieved and particles of the proper size range are gathered and packaged.
  • the powders after blending, or simultaneously with blending are moistened with water, a hydroalcoholic solution, or low concentration dispersion of one or more of the water dispersable hydrocolloids in water or hydroalcoholic vehicles.
  • the amount of moisture added is up to about 50% of the dry weight of the powders in order to form granules with adequate process-ability and resistance to attrition.
  • the moistened mass is forced through a screen or die to yield granules directly or to yield by extrusion, a particulate noodle-like or ribbon-like mass of material. When dried, this material is then milled to the desired sieve size and packaged.
  • the moistened mass may first be broken into large lumps which are then dried and milled to the desired particle size.
  • the moistening fluid is added to a charge of the blended powders held suspended on a column of rising warm air where the powders are allowed to mix with the granulating fluid, which is very rapidly evaporated, leaving behind agglomerated granules. Less moistening fluid is required in this process then in the wet granulation process described above.
  • the use of the occlusive dressings described above results in a closed moist wound treatment environment.
  • the ingredients employed in adhesive layer 14 permit the dressings of this invention to remain in place over the wound for up to several days. It is believed that the need to frequently change a dressing disturbs the wound healing environment and results in a slower healing process.
  • the water dispersable hydrocolloid materials, distributed throughout adhesive layer 14 react in the presence of moisture.
  • the layer 14 will gradually hydrate over a period of days.
  • the initial aggressive bond of the dressing to this normal skin is due to the presence of the pressure sensitive adhesive materials in layer 14; i.e., dry tack.
  • the wet tack of the moisture active ingredients in layer 14 becomes more critical in bonding the dressing to the skin.
  • layer 14 becomes so hydrated that the dressing can be removed without stripping or macerating the skin around the wound site.
  • Fig. 7 shows an ulcer 70 covered by occlusive dressing 10.
  • the dressing is partially broken away to show the granular packing material 75.
  • adhesive layer 14 contacts the granules 75 in the area of the wound and also bonds the dressing to the normal skin 71 surrounding the ulcer.

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Claims (15)

  1. Okklusiver mehrschichtiger Wundverband (10, 30, 50), umfassend eine Klebemittelschicht (14), die bei Gebrauch mit der Wunde und der umgebenden normalen Haut in Berührung kommt, eine Zwischenschicht (12) aus polymerem Schaum mit halboffenen Zellen und eine äußere feuchtigkeitsundurchlässige Polymerfolie (11), die auf die obere Fläche der Schaumschicht (12) aufgebracht oder laminiert ist, wobei die Wunde und Haut berührende Klebemittelschicht (14) im wesentlichen aus einem homogenen Gemisch von etwa 35 bis etwa 50 Gew.-% eines oder mehrerer Polyisobutylene niederen Molekulargewichts, die als Haftkleber wirken und aus etwa 45 bis etwa 65 Gew.-% eines oder mehrerer in Wasser dispergierbarer Hydrokolloide, ausgewählt aus Natriumcarboxymethylcellulose, Calciumcarboxymethylcellulose, Pektin, Gelatine, Guargummi, Karobbegummi, Kollagen und Karayagummi besteht.
  2. Verband nach Anspruch 1, wobei die Wunde und Haut berührende Klebemittelschicht (14) ein homogenes Gemisch aus etwa 40 Gew.-% eines Polyisobutylens niederen Molekulargewichts, etwa 20 Gew.-% Natriumcarboxymethylcellulose, etwa 20 Gew.-% Pektin und etwa 20 Gew.-% Gelatine ist.
  3. Verband nach Anspruch 2, wobei der polymere Schaum mit offenen Zellen (12) ein Polyurethanschaum ist und die wasserundurchlässige Polymerfolie (11) aus Polyurethan besteht.
  4. Verband nach Anspruch 3, wobei die Wunde und Haut berührende Klebemittelschicht (14) etwa 0,02 Zoll (0,5 mm) bis etwa 0,1 Zoll (2,54 mm) stark ist, die Polyurethanschaumschicht (12) etwa 0,03 Zoll (0,76 mm) bis etwa 0,1 Zoll (2,54 mm) stark ist und die wasserundurchlässige Polyurethanfolie (11) etwa 0,001 Zoll (0,0254 mm) bis etwa 0,003 Zoll (0,076 mm) stark ist.
  5. Verband nach einem vorangehenden Anspruch, wobei die Wunde und Haut berührende Klebemittelschicht (14) direkt an die untere Fläche der Schaumschicht (12) gebunden ist.
  6. Verband nach Anspruch 1, wobei die Wunde und Haut berührende Klebemittelschicht (14) durch eine zweite Klebemittelschicht (13) an den polymeren Schaum mit offenen Zellen (12) gebunden ist und die zweite Klebemittelschicht (13) im wesentlichen aus einem homogenen Gemisch aus etwa 30 bis etwa 70 Gew.-% eines oder mehrerer Haftkleber und einem oder mehreren gegebenenfalls thermoplastischen Elastomeren, etwa 10 bis etwa 65 Gew.-% eines oder mehrerer wasserdispergierbarer Hydrokolloide und bis zu 50 Gew.-% eines oder mehrerer gegebenenfalls in Wasser quellbarer kohäsiv verfestigender Mittel und/oder eines oder mehrerer gegebenenfalls hydratisierbarer Polymere; etwa 5 bis etwa 15 Gew.-% eines Weichmachers oder Lösungsmittels und etwa 15 bis etwa 25 Gew.-% eines Haftmittels besteht, mit der Maßgabe, daß die in Wasser dispergierbaren Hydrokolloide, in Wasser quellbaren kohäsiv verfestigenden Mittel und die hydratisierbaren Polymeren zusammen nicht mehr als 70 Gew.-% der Klebemittelschicht ausmachen.
  7. Verband nach Anspruch 6, wobei in der zweiten Klebemittelschicht (13) der Haftkleber ausgewählt ist aus Naturkautschuk, Silikonkautschuk, Acrylnitrilkautschuk, Polyurethankautschuk und Polyisobutylenen niederen Molekulargewichts, das gegebenenfalls thermoplastische Elastomer, falls vorhanden, ausgewählt ist aus Polyisobutylenen mittleren Molekulargewichts, Butylkautschuk, Styrol-Butadien-Styrol-Copolymerisaten, Styrol-Isopren-Styrol-Copolymerisaten und Styrol-Ethylen/Butylen-Styrol-Copolymerisaten, das in Wasser dispergierbare Hydrokolloid ausgewählt ist aus Natriumcarboxymethylcellulose, Calciumcarboxymethylcellulose, Pektin, Gelatine, Guargummi, Karobbegummi, Kollagen und Karayagummi, das gegebenenfalls in Wasser quellbare kohäsiv verfestigende Mittel, falls vorhanden, ausgewählt ist aus wasserunlöslicher vernetzter Natriumcarboxymethylcellulose, wasserunlöslichem Stärke-Acrylnitril-Pfropfcopolymerisat und wasserunlöslichem vernetztem Dextran, das gegebenenfalls hydratisierbare Polymer, falls vorhanden, ausgewählt ist aus Gluten und langkettigen Polymerisaten von Methylvinylether/Maleinsäure, der Weichmacher oder das Lösungsmittel Mineralöl ist und das Haftmittel ein Terpenharz ist.
  8. Verband nach Anspruch 7, wobei die zweite Klebemittelschicht (13) ein homogenes Gemisch aus etwa 35 bis etwa 50 Gew.-% Polyisobutylenen niederen Molekulargewichts und einem oder mehreren, gegebenenfalls thermoplastischen Elastomeren, ausgewählt aus Polyisobutylenen mittleren Molekulargewichts, Butylkautschuk und Styrol-Isopren-Styrol-Copolymerisaten, etwa 30 bis 50 Gew.-% eines oder mehrerer wasserdispergierbarer Hydrokolloide, einem oder mehreren gegebenenfalls in Wasser quellbaren kohäsiv verfestigenden Mitteln und einem oder mehreren gegebenenfalls hydratisierbaren Polymeren, etwa 5 bis etwa 15 Gew.-% Mineralöl und etwa 15 bis etwa 25 Gew.-% eines Terpenharz-Haftmittels ist.
  9. Verband nach Anspruch 8, wobei die Wunde und Haut berührende Klebemittelschicht (14) ein homogenes Gemisch aus etwa 40 Gew.-% Polyisobutylen niederen Molekulargewichts, etwa 20 Gew.-% Natriumcarboxymethylcellulose, etwa 20 Gew.-% Pektin und etwa 20 Gew.-% Gelatine ist.
  10. Verband nach Anspruch 9, wobei die zweite Klebemittelschicht (13) ein homogenes Gemisch aus etwa 18 Gew.-% Polyisobutylenen niederen Molekulargewichts, etwa 20 Gew.-% Polyisobutylenen mittleren Molekulargewichts, etwa 18 Gew.-% Natriumcarboxymethylcellulose, etwa 15 Gew.-% Gelatine, etwa 20 Gew.-% Terpenharz, etwa 8,5 Gew.-% Mineralöl und etwa 0,5 Gew.-% butyliertes Hydroxytoluol ist.
  11. Verband nach Anspruch 10, wobei der polymere Schaum mit offenen Zellen ein Polyurethanschaum ist und die wasserundurchlässige Polymerfolie aus Polyurethan besteht.
  12. Verband nach Anspruch 11, wobei die Wunde und Haut berührende Klebemittelschicht (14) etwa 0,02 Zoll (0,05 mm) bis etwa 0,1 Zoll (2,54 mm) stark ist, die zweite Klebemittelschicht etwa 0,005 Zoll (0,127 mm) bis etwa 0,02 Zoll (0,5 mm) stark ist, die Polyurethanschaumschicht etwa 0,03 Zoll (0,76 mm) bis etwa 0,1 Zoll (2,54 mm) stark ist und die wasserundurchlässige Polyurethanschicht etwa 0,001 Zoll (0,0254 mm) bis etwa 0,003 Zoll (0,076 mm) stark ist.
  13. Verband nach Anspruch 6, wobei eine Schicht (31) aus desodorierendem Material zwischen den zwei Klebemittelschichten (14, 13) eingefügt ist.
  14. Verband nach Anspruch 13, wobei die Schicht (31) des desodorierenden Materials Aktivkohle enthält.
  15. Verfahren zur Herstellung eines Mehrschichtverbands gemäß Anspruch 6, umfassend die Herstellung eines homogenen Teiges, im wesentlichen bestehend aus einem oder mehreren Polyisobutylenen niederen Molekulargewichts und einem oder mehreren Hydrokolloiden, durch mechanisches Vermischen, Herstellen einer Klebeschicht durch Vermischen eines oder mehrerer Hydrokolloidgummis, eines oder mehrerer Haftkleber, Haftmittel und Weichmacher in einem organischen Lösungsmittel, wie Heptan oder Hexan, Aufbringen der so erhaltenen Klebemittelaufschlämmung auf ein silikonbeschichtetes Abstreifpapier und Verdampfen des Lösungsmittels wodurch das getrocknete Hydrokolloid in der gesamten Klebemittelschicht dispergiert wird, Aufdrücken eines Laminats aus flexiblem polymeren Schaum mit halboffenen Zellen mit einer wasserundurchlässigen polymeren Beschichtung oder Haut auf einer Seite und Abstreifen des silikonbeschichteten Abstreifpapiers von der Klebeschicht und Zusammenpressen der Klebeschichten unter Anwendung von Wärme zum Verband.
EP83302316A 1982-04-22 1983-04-22 Wundverband Revoked EP0092999B1 (de)

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EP0512855A2 (de) * 1991-05-09 1992-11-11 E.R. Squibb & Sons, Inc. Absorbierendes Wundenausfüllmittel
EP0528191A1 (de) * 1991-07-22 1993-02-24 Nitto Denko Corporation Verband
GB2259464A (en) * 1991-09-11 1993-03-17 Robinson & Sons Ltd Hydrocolloid dressing
EP0630216A1 (de) * 1992-03-05 1994-12-28 PODELL, Howard I. Adhesive bandagen, wundverbände, nähte, laken, orthodontische gummibänder, zahnbürsten und ähnliches
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WO1996008367A2 (en) * 1994-09-16 1996-03-21 Avery Dennison Corporation Multilayer pressure-sensitive adhesive construction
EP0771568A1 (de) 1995-11-01 1997-05-07 Bristol-Myers Squibb Company Verwendung eines Klebstoffes bei der Herstellung von Wundverbänden
US5643187A (en) * 1992-01-17 1997-07-01 Coloplast A/S Dressing
US5830496A (en) * 1993-09-13 1998-11-03 E.R. Squibb & Sons, Inc. Wound filler
US5914125A (en) * 1991-02-07 1999-06-22 Ultra Laboratories Limited Wound dressing
GB2333711A (en) * 1996-10-22 1999-08-04 Smith & Nephew Absorbant dressing
US6051249A (en) * 1995-01-27 2000-04-18 Coloplast A/S Dressing having a three-dimensional part and processes for the preparation of such a dressing
WO2004058133A2 (en) 2002-12-31 2004-07-15 Cst Medical Ltd Device for applying a tactile stimulus
SG111977A1 (en) * 2002-11-12 2005-06-29 Biopol Co Ltd Multilayered microporous foam dressing and method for manufacturing the same
US7759537B2 (en) 2004-02-13 2010-07-20 Convatec Technologies Inc. Multi layered wound dressing
DE102011120491A1 (de) * 2011-09-02 2013-03-07 BLüCHER GMBH Wundauflage
US8513218B2 (en) 2010-03-31 2013-08-20 Millennium Pharmaceuticals, Inc. Derivatives of 1-amino-2-cyclopropylethylboronic acid
US8664200B2 (en) 2008-09-29 2014-03-04 Millennium Pharmaceuticals, Inc. Derivatives of 1-amino-2-cyclobutylethylboronic acid
US8772536B2 (en) 2007-08-06 2014-07-08 Millennium Pharmaceuticals, Inc. Proteasome inhibitors
US8859504B2 (en) 2008-06-17 2014-10-14 Millennium Pharmaceuticals, Inc. Boronate ester compounds and pharmaceutical compositions thereof
US9358318B2 (en) 2004-10-20 2016-06-07 Ethicon, Inc. Method of making a reinforced absorbable multilayered hemostatic wound dressing
US9439997B2 (en) 2004-10-20 2016-09-13 Ethicon, Inc. Reinforced absorbable multilayered hemostatis wound dressing
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US4583976A (en) * 1984-05-31 1986-04-22 E. R. Squibb & Sons, Inc. Catheter support
EP0190814A2 (de) * 1985-01-04 1986-08-13 E.R. Squibb & Sons, Inc. Wundverband
EP0190814A3 (en) * 1985-01-04 1988-05-18 E.R. Squibb & Sons, Inc. Wound dressing
US4773408A (en) * 1985-01-04 1988-09-27 E. R. Squibb & Sons, Inc. Wound dressing
US4773409A (en) * 1985-09-20 1988-09-27 E. R. Squibb & Sons, Inc. Wound dressing
EP0249694A2 (de) * 1986-06-11 1987-12-23 Hollister Incorporated Okklusiver Wundverband
EP0249694A3 (en) * 1986-06-11 1989-03-01 Hollister Incorporated Occlusive wound care dressing
US5914125A (en) * 1991-02-07 1999-06-22 Ultra Laboratories Limited Wound dressing
EP0512855A2 (de) * 1991-05-09 1992-11-11 E.R. Squibb & Sons, Inc. Absorbierendes Wundenausfüllmittel
EP0512855A3 (en) * 1991-05-09 1993-03-10 E.R. Squibb & Sons, Inc. Absorbent wound filler
EP0528191A1 (de) * 1991-07-22 1993-02-24 Nitto Denko Corporation Verband
US5429591A (en) * 1991-07-22 1995-07-04 Nitto Denko Corporation Absorbent dressing having backing and continuous adhesive layer
GB2259464B (en) * 1991-09-11 1995-07-12 Robinson & Sons Ltd Hydrocolloid dressing
GB2259464A (en) * 1991-09-11 1993-03-17 Robinson & Sons Ltd Hydrocolloid dressing
US5643187A (en) * 1992-01-17 1997-07-01 Coloplast A/S Dressing
EP0630216A1 (de) * 1992-03-05 1994-12-28 PODELL, Howard I. Adhesive bandagen, wundverbände, nähte, laken, orthodontische gummibänder, zahnbürsten und ähnliches
US5830496A (en) * 1993-09-13 1998-11-03 E.R. Squibb & Sons, Inc. Wound filler
WO1996008367A2 (en) * 1994-09-16 1996-03-21 Avery Dennison Corporation Multilayer pressure-sensitive adhesive construction
US6051249A (en) * 1995-01-27 2000-04-18 Coloplast A/S Dressing having a three-dimensional part and processes for the preparation of such a dressing
EP0771568A1 (de) 1995-11-01 1997-05-07 Bristol-Myers Squibb Company Verwendung eines Klebstoffes bei der Herstellung von Wundverbänden
GB2333711A (en) * 1996-10-22 1999-08-04 Smith & Nephew Absorbant dressing
SG111977A1 (en) * 2002-11-12 2005-06-29 Biopol Co Ltd Multilayered microporous foam dressing and method for manufacturing the same
WO2004058133A2 (en) 2002-12-31 2004-07-15 Cst Medical Ltd Device for applying a tactile stimulus
US7759537B2 (en) 2004-02-13 2010-07-20 Convatec Technologies Inc. Multi layered wound dressing
US9439997B2 (en) 2004-10-20 2016-09-13 Ethicon, Inc. Reinforced absorbable multilayered hemostatis wound dressing
US9358318B2 (en) 2004-10-20 2016-06-07 Ethicon, Inc. Method of making a reinforced absorbable multilayered hemostatic wound dressing
US8772536B2 (en) 2007-08-06 2014-07-08 Millennium Pharmaceuticals, Inc. Proteasome inhibitors
US8871745B2 (en) 2007-08-06 2014-10-28 Millennium Pharmaceuticals, Inc. Proteasome inhibitors
US8859504B2 (en) 2008-06-17 2014-10-14 Millennium Pharmaceuticals, Inc. Boronate ester compounds and pharmaceutical compositions thereof
US9175017B2 (en) 2008-06-17 2015-11-03 Millennium Pharmaceuticals, Inc. Boronate ester compounds and pharmaceutical compositions thereof
US9175018B2 (en) 2008-06-17 2015-11-03 Millennium Pharmaceuticals, Inc. Boronate ester compounds and pharmaceutical compositions thereof
US10526351B2 (en) 2008-06-17 2020-01-07 Millennium Pharmaceuticals, Inc. Boronate ester compounds and pharmaceutical compositions thereof
US10604538B2 (en) 2008-06-17 2020-03-31 Millenium Pharmaceuticals, Inc. Boronate ester compounds and pharmaceutical compositions thereof
US11485746B2 (en) 2008-06-17 2022-11-01 Millennium Pharmaceuticals, Inc. Boronate ester compounds and pharmaceutical compositions thereof
US8664200B2 (en) 2008-09-29 2014-03-04 Millennium Pharmaceuticals, Inc. Derivatives of 1-amino-2-cyclobutylethylboronic acid
US11458044B2 (en) 2008-09-29 2022-10-04 Convatec Technologies Inc. Wound dressing
US8703743B2 (en) 2010-03-31 2014-04-22 Millennium Pharmaceuticals, Inc. Derivatives of 1-amino-2-cyclopropylethylboronic acid
US8513218B2 (en) 2010-03-31 2013-08-20 Millennium Pharmaceuticals, Inc. Derivatives of 1-amino-2-cyclopropylethylboronic acid
DE102011120491A1 (de) * 2011-09-02 2013-03-07 BLüCHER GMBH Wundauflage
US11241448B2 (en) 2014-05-20 2022-02-08 Millennium Pharmaceuticals, Inc. Methods for cancer therapy
WO2021130475A1 (en) 2019-12-27 2021-07-01 Convatec Limited Negative pressure wound dressing

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EP0092999A3 (en) 1986-02-26
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ATE74280T1 (de) 1992-04-15
DK161305C (da) 1998-05-18
DK175783A (da) 1983-10-23
EG17028A (en) 1991-03-30
NO831412L (no) 1983-10-24
IN159044B (de) 1987-03-14
DK161305B (da) 1991-06-24
DE3382643D1 (de) 1992-12-24
AU1356583A (en) 1983-10-27
IE60457B1 (en) 1994-07-13
AU569031B2 (en) 1988-01-21
NO157686B (no) 1988-01-25
ES8403726A1 (es) 1984-04-01
NZ203706A (en) 1986-03-14
DK175783D0 (da) 1983-04-21
JPS58190446A (ja) 1983-11-07
ES521696A0 (es) 1984-04-01
CA1220422A (en) 1987-04-14
IL68424A0 (en) 1983-07-31
NO157686C (no) 1988-05-11
EP0092999A2 (de) 1983-11-02
DE3382643T2 (de) 1993-04-15
BR8301958A (pt) 1983-12-20
DD209573A5 (de) 1984-05-16
KR840004367A (ko) 1984-10-15
IL68424A (en) 1986-10-31
DE3382538D1 (de) 1992-05-07
JPH0613045B2 (ja) 1994-02-23
ZA832413B (en) 1983-12-28

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